Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines Second Edition
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Clinical Trials: Study Design, Endpoints and Biomarkers, Drug Safety, and FDA and ICH Guidelines Second Edition – Ebook Instant Download/Delivery ISBN(s): 9780128042175,0128042176,9780128042588, 0128042583
Product details:
- ISBN-10: 0128042583
- ISBN-13: 9780128042588
- Author: Brody Tom
Clinical Trials, Second Edition, offers those engaged in clinical trial design a valuable and practical guide. This book takes an integrated approach to incorporate biomedical science, laboratory data of human study, endpoint specification, legal and regulatory aspects and much more with the fundamentals of clinical trial design. It provides an overview of the design options along with the specific details of trial design and offers guidance on how to make appropriate choices. Full of numerous examples and now containing actual decisions from FDA reviewers to better inform trial design, the 2nd edition of Clinical Trials is a must-have resource for early and mid-career researchers and clinicians who design and conduct clinical trials.
Table contents:
Chapter 1. Origins of Drugs
Chapter 2. Clinical Trial Design
Chapter 3. Run-In Period
Chapter 4. Inclusion/Exclusion Criteria, Stratification, and Subgroups—Part I
Chapter 5. Inclusion/Exclusion Criteria, Stratification, and Subgroups—Part II
Chapter 6. Blinding, Randomization, and Allocation
Chapter 7. Placebo Arm as Part of Clinical Trial Design
Chapter 8. Intent-to-Treat Analysis Versus Per Protocol Analysis
Chapter 9. Biostatistics—Part I
Chapter 10. Biostatistics—Part II
Chapter 11. Introduction to Endpoints
Chapter 12. Oncology Endpoint—Objective Response
Chapter 13. Oncology Endpoints: Overall Survival and Progression-Free Survival
Chapter 14. Oncology Endpoints: Time to Progression
Chapter 15. Oncology Endpoint: Disease-Free Survival
Chapter 16. Oncology Endpoint: Time to Distant Metastasis
Chapter 17. Neoadjuvant Therapy Versus Adjuvant Therapy
Chapter 18. Hematological Cancers
Chapter 19. Biomarkers
Chapter 20. Endpoints for Immune Diseases
Chapter 21. Endpoints for Infections
Chapter 22. Health-Related Quality of Life Tools—Oncology
Chapter 23. Health-Related Quality-of-Life Tools—Immune Disorders
Chapter 24. Health-Related Quality-of-Life Tools—Infections
Chapter 25. Drug Safety
Chapter 26. Mechanism of Action of Diseases and Drugs—Part I
Chapter 27. Mechanism of Action—Part II (Cancer)
Chapter 28. Mechanism of Action—Part III (Immune Disorders)
Chapter 29. Mechanisms of Action—Part IV (Infections)
Chapter 30. Consent Forms
Chapter 31. Package Inserts
Chapter 32. Warning Letters
Chapter 33. Regulatory Approval
Chapter 34. Patents
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